Description

Ticagrelor Diastereomer is a specific stereoisomeric form of the active pharmaceutical ingredient Ticagrelor, a key P2Y12 platelet inhibitor. This high-purity reference standard is critical for analytical method development, quality control, and regulatory compliance in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies involved in the development, production, and testing of antiplatelet medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the diastereomer in Ticagrelor drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to separate and analyze stereoisomeric impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for impurity profiling to ensure the stereochemical purity of the final Active Pharmaceutical Ingredient (API).
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing data on impurity characterization and control strategies.
• Pharmacological Research: Used in studies to understand the stereospecific activity, metabolism, and pharmacokinetics of Ticagrelor and its related compounds.
• Stability Studies: Employed to monitor the formation of diastereomeric impurities under various stress conditions during drug product shelf-life studies.

Basic Information

Product Name	Ticagrelor Diastereomer
CAS No.	1459719-81-3
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol; Ticagrelor Stereoisomer; Ticagrelor Related Compound; AZD6140 Diastereomer; AR-C126913XX Diastereomer
EINECS	Contact for details

Quality Control

Our Ticagrelor Diastereomer is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for stereochemical purity, NMR for structural confirmation, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, identity, and impurity profiles to support cGMP and ICH Q3A/B guidelines for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Diastereomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.